Cosmetics

Warning Letters Cite Cosmetics as Adulterated Due to Violative Use of Canthaxanthin

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is illegal to market an adulterated cosmetic in interstate commerce (FD&C Act, section 301(a). Under the law, one of the ways a cosmetic can become adulterated is if it contains a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act (FD&C Act, sec. 601(e)).

FDA issued warning letters to the following firms, citing cosmetic products as adulterated due to the violative use of a color additive. In these cases, products containing canthaxanthin were marketed for use in coloring the skin to simulate a tan, which is not a permitted use for this color additive.